Sleep Apnea Treatment System and Improvements Thereto

ABSTRACT

A valve structure for treating a patient suffering from obstructive sleep apnea is provided. The valve structure is connected to an air flow generator and connected to a mask that covers at least the nostrils of a patient. The valve structure includes an inlet pressure port attached to the air flow generator and an expiration valve that includes an expiratory membrane, a primary seat and a secondary seat. During inspiration the expiratory membrane forms a seal with the primary seat, and during expiration, the expiratory membrane forms a seal with the secondary seat.

RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No. 62/532240 filed Jul. 13, 2017 titled “Sleep Apnea Treatment System and Improvements Thereto”. This application also claims priority as a continuation-in-part to U.S. patent application Ser. No. 15/557907 filed Sep. 13, 2017 titled “Apparatus, Systems, And Methods For Treating Obstructive Sleep Apnea”, which in turn claims priority to PCT/US2016/023798 filed on Mar. 23, 2016 titled “Apparatus, Systems, And Methods For Treating Obstructive Sleep Apnea”, which in turn claims priority to U.S. patent application Ser. No. 14/930284 filed on Nov. 2, 2015 titled “Apparatus, Systems, And Methods For Treating Obstructive Sleep Apnea”. This application also claims priority as a continuation-in-part to U.S. patent application Ser. No. 15/910937 filed Mar. 2, 2018 titled “Sound Mitigation Structures and Methods for Use in Treating Obstructive Sleep Apnea”, which in turn claims priority to U.S. Provisional Application No. 62/465905 filed on Mar. 2, 2017 titled “Sound Mitigation/Flow Optimization in a Valved Obstructive Sleep Apnea Treatment Mask”. This application also claims priority as a continuation-in-part to U.S. patent application Ser. No. 15/334243 filed on Oct. 25, 2016 titled “Apparatus, Systems, And Methods For Treating Obstructive Sleep Apnea”, which in turn claims priority to U.S. Provisional Application No. 62/311804 filed Mar. 22, 2016 titled “Improvements to Sleep Apnea System.” This application also claims priority to U.S. Provisional application No. 62/694126 filed on Jul. 5, 2018 titled “Braided Hose For Use In Sleep Apnea Treatment Systems That Decouples Forces.” All of the foregoing applications are hereby incorporated by reference in their entirety.

The assignee of this application, FRESCA Medical, has described various embodiments of its valved Positive Airway Pressure (PAP) sleep apnea treatment mask. Those embodiments are described in U.S. patent application Ser. No. 13/860,926, filed Apr. 11, 2013, titled “Sleep Apnea Device,” U.S. Provisional Application Ser. No. 61/623,855, filed Apr. 13, 2012, titled “Sleep Apnea Device,” U.S. Provisional Application Ser. No. 61/775,430, filed Mar. 8, 2013, titled “Sleep Apnea Device,” U.S. Provisional Application No. 61/823,553, filed May 15, 2013, titled “Sleep Apnea Device,” U.S. Provisional Application No. 61/838,191, filed Jun. 21, 2013, titled “Sleep Apnea Device,” U.S. Provisional Application No. 61/962,501, filed Nov. 8, 2013, titled “Sleep Apnea Device,” U.S. Provisional Application No. 61/909,956, filed Nov. 27, 2013, titled “Sleep Apnea Device,” U.S. Provisional Application No. 61/927,355, filed Jan. 14, 2014, titled “Valve with Pressure Feedback,” U.S. Provisional Application No. 62/134,506 filed Mar. 17, 2015 titled “Valve with Pressure Feedback Draft Provisional Application,” U.S. Provisional Application No. 62/163,601, filed May 19, 2015, titled “Airflow Generator with Delayed Onset”, U.S. Provisional Application No. 62/184,787 filed Jun. 25, 2015 titled “Sleep Apnea Device,” U.S. Provisional Application No. 62/239,146 filed Oct. 8, 2015 titled “Sleep Apnea Device,” U.S. patent application Ser. No. 14/930,284, filed Nov. 2, 2015, titled “Apparatus, System and Methods for Treating Obstructive Sleep Apnea”, U.S. Provisional Application No. 62/246,339 filed Oct. 26, 2015 titled “Venting of a Valved CPAP Mask to Create a Comfortable Breathing Sensation”, U.S. Provisional Application No. 62/246,489 filed Oct. 26, 2015 titled “Managing Sleep Apnea with Pulse Oximeters and With Additional Assessment Tools”, U.S. Provisional Application No. 62/246,328 filed Oct. 26, 2015 titled “Novel Low Flow Technology Designed to Meet CPAP Efficacy”, U.S. Provisional Application No. 62/246,477 filed Oct. 26, 2015 titled “Composite Construction Air Delivery Hose for USE with CPAP Treatment”, U.S. Provisional Application No. 62/275899 filed Jan. 7, 2016 titled “Valved Mask To Reduce and Prevent Snoring”, U.S. Provisional Application No. 62/311804 filed Mar. 22, 2016 titled “Improvements to Sleep Apnea Machine”, U.S. Provisional Application No. 62/382980 filed Sep. 2, 2016 titled “Dual Rotatable Hose For Use With CPAP Treatment”, U.S. application Ser. No. 15/334243 filed Oct. 15, 2016 titled “Apparatus, Systems, And Methods For Treating Obstructive Sleep Apnea”, U.S. Provisional Application No. 62/532240 filed Jul. 13, 2017 titled “Sleep Apnea Treatment System and Improvements Thereto”, U.S. Provisional Application No. 62/595529 filed Dec. 6, 2017 titled “Sleep Apnea Treatment System and Improvements Thereto”, and U.S. Provisional Application No. 62/465905 filed Mar. 2, 2017 titled “Sound Mitigation/Flow Optimization in a Valved Obstructive Sleep Apnea Treatment Mask”, all of which are hereby incorporated by reference in their entirety. Disclosed in this document are particular features and structures that may be used in conjunction with the previously disclosed embodiments.

TECHNICAL FIELD

The present invention is related to medical systems, devices, and methods. More specifically, the invention is related to systems, devices and methods for treating obstructive sleep apnea or snoring.

BACKGROUND

Obstructive sleep apnea (OSA) is a common medical disorder that can be quite serious. It has been reported that approximately one in twenty-two Americans (about 12, 000, 000 people) suffer from OSA, and many cases go undiagnosed. Chronic fatigue has long been recognized as the hallmark of OSA, but more recently, large clinical studies have shown a strong link between OSA, strokes and death.

Obstructive sleep apnea is a condition in which the flow of air pauses or decreases during breathing while one is asleep because the airway has become narrowed, blocked, or floppy. (See FIG. 1A of published patent application US20140246025 A1 to Cragg et al., published Sep. 4, 2014, which is incorporated herein by reference, illustrating an airway during normal breathing and FIG. 1B therein illustrating the airway A during OSA.) A pause in breathing is called an apnea episode, while a decrease in airflow during breathing is called a hypopnea episode. Almost everyone has brief apnea or hypopnea episodes while they sleep. In OSA, however, apnea episodes occur more frequently and last longer than in the general population. OSA has become an increasingly costly medical condition in recent years, as the disorder is more prevalent in obese people and obesity has become significantly more prevalent. Unfortunately, the currently available options for treating OSA are not ideal.

A person with OSA usually begins snoring heavily soon after falling asleep. Often the snoring gets louder. The snoring is then interrupted by a long silent period during which there is no breathing. This is followed by a loud snort and gasp, as the person attempts to breathe. This pattern repeats. Many people wake up unrefreshed in the morning and feel sleepy or drowsy throughout the day. This is called excessive daytime sleepiness (EDS). People with sleep apnea may act grumpy or irritable, be forgetful, fall asleep while working, reading, or watching TV, feel sleepy or even fall asleep while driving, or have hard-to-treat headaches. OSA sufferers may also experience depression that becomes worse, hyperactive behavior (especially in children), or leg swelling (if severe).

The most widely used therapy for OSA is Continuous Positive Airway Pressure (CPAP). As shown in FIG. 2 of US20140246025 A1 to Cragg et al., a CPAP system 10 typically consists of a mask 12a-12c fitting in or over the nose or nose and mouth, an air pressurizing console 14, and a tube 16 connecting the two (typically a six-foot long hose with a 20 mm diameter bore). CPAP works by pressurizing the upper airway throughout the breathing cycle, essentially inflating the airway to keep it open and thus creating what is sometimes referred to as a “pneumatic splint.” This flow is set at a pressure that has been predetermined through medical testing to be appropriate to create a pneumatic splint in the user's airway. This prevents airway collapse and allows the user to breathe without obstruction. Because the masks 12a-12c typically leak air, CPAP systems have to provide an airflow rate of up to 200 liters per minute (approximate figure based on unpublished data). The high airflow rate is needed for multiple reasons. First, all the air needed for breathing must come through the hose. Second, conventional masks have an intended leak built in for the purpose of constant “CO₂ washout.” Third, these systems achieve the required pressure by using a high airflow rate to generate a back-pressure at the mask end where the air is leaking out. Unfortunately, this high flow rate makes breathing feel quite uncomfortable for many users and requires a relatively large, noisy pressurizing console 14. Additionally, the high required flow rates of CPAP often cause discomfort during exhalation due to increased resistance, as well as nasal dryness, dry mouth, ear pain, rhinitis, abdominal bloating and headaches.

The overwhelming shortcoming of CPAP is poor user compliance. Over half of all users who try CPAP stop using it. Users dislike the side effects mentioned above, as well as having to wear an uncomfortable, claustrophobic mask, being tethered to a pressurizing console, the noise of the console, traveling with a bulky device, and a loss of personal space in bed.

Many CPAP devices and alternatives to CPAP have been developed, but all have significant shortcomings. Less invasive attempts at OSA treatment, such as behavior modification, sleep positioning and removable splints to be worn in the mouth, rarely work. A number of different surgical approaches for treating OSA have also been tried, some of which are still in use. For example, Uvulopalatopharyngoplasty (UPPP) and Laser Assisted Uvula Palatoplasty (LAUP) are currently used. Surgical approaches, however, are often quite invasive and not always effective at treating OSA.

One alternative approach to OSA treatment is to provide a pneumatic splint during the expiratory portion of the respiratory cycle by producing a partial blockage in the nose or mouth, thus slowing the release of air during expiration and increasing positive pressure in the airway. The simplest way to form an expiratory pneumatic splint, pursing the lips, has been shown to open the upper airway and improve breathing in emphysema users. This type of maneuver is generically labeled Expiratory Positive Airway Pressure (EPAP).

Ventus Medical, Inc. (http://www.proventtherapy.com/ventus_medical) has developed a removable nasal EPAP device to produce such a pneumatic splint during exhalation (the Provent® Sleep Apnea Therapy). (See, for example, published patent application US20060150978 A1 to Doshi et al., published Jul. 13, 2006, which is incorporated herein by reference.) This device restricts exhalation by forcing expired air through several small orifices attached to the nose. This is labeled a Fixed Orifice Resistor (FOR). Shortcomings of this therapy are that 1) the fixed hole exhalation valve does not have a capped maximum pressure, 2) the pressure increases immediately upon exhalation and therefore makes it difficult to exhale, and 3) with no assistance of additional pressure from an external source, if the user has an apneic event there is no ‘rescue pressure’—i.e., the flow supplied by the blower box. A further disadvantage is that the Provent® device or any FOR restricts expiratory airflow using a fixed hole for resistance. This leads to an uncomfortable spike in nasal pressure at the beginning of expiration when airflow is highest and a less efficacious decrease in nasal pressure at the end of expiration when airflow is lowest. Another shortcoming of the Provent® device is that it produces the pneumatic splint only during exhalation—i.e., there is no increased pressure during inhalation.

In addition, the device is not effective in mouth breathers or users who become mouth breathers when resistance is added to the nasal passages. Thus, the Provent® device is useful only in moderate cases of OSA that do not convert to mouth breathing.

Although snoring is not as severe a condition as OSA, it does affect lives adversely. Snoring can adversely affect sleep quality and can make sleeping with a spouse or other partner difficult. Although many snoring therapies have been tried, including Breathe Right® Nasal Strips and more invasive approaches in more severe cases, no ideal solution has been found.

Therefore, it would be advantageous to have improved systems, devices and methods for treating OSA and snoring. Ideally, such systems, devices and methods would be less cumbersome than currently available CPAP systems, to improve user compliance. Also ideally, such systems, devices and methods would provide some of the advantages of an expiratory pneumatic splint. At least some of these objectives were met by the embodiments described in US20140246025 A1 to Cragg et al., previously incorporated herein by reference (herein sometimes referred to as “Cragg '025”).

Cragg '025 utilized a novel system of valves to allow inspiration of air supplied via the hose and also from inlets in the mask that take in room air. In various example embodiments Cragg '025 provided variable resistance to expiratory air flow using a resistive mechanism other than infused external air that increases over the course of expiration, thus providing an easier, more comfortable start to expiration while maintaining airway pressure toward the end of expiration (e.g., by decreasing resistance to expiratory flow when intranasal pressure reaches a threshold pressure and/or by gradually increasing resistance to expiratory air flow until intranasal pressure reaches the threshold pressure). Another improvement in various embodiments of Cragg '025 was that lower air flow rates were used (e.g., less than or equal to 20 L/min), while still supplying the desired therapeutic pressure (e.g., between about 4 cm H₂O and 20 cm H₂O), thus requiring less power and smaller device components than traditional CPAP and reducing side effects. Still another improvement of Cragg '025 was a less cumbersome, more form-fitting mask that reduced air leaks and was more comfortable to wear than prior CPAP masks and eliminated the need for high flow rates because there was no need to compensate for air leaks. Accordingly, the devices described therein could be used in connection with a small diameter hose (e.g., having a diameter of less than or equal to about 15 mm), thus decreasing the bulkiness of the system.

While Cragg '025 was an important improvement over the state of the art, it required and relied upon a special system of protruding valves that had to be pre-adjusted or set to suit each user. It would be advantageous to improve upon the system of Cragg '025 by making the system simpler and more compact in design, simpler to use, and more robust.

SUMMARY

Provided in various example embodiments is an improved apparatus, system, and method for treating obstructive sleep apnea. Specifically, a novel valve structure for treating a patient suffering from obstructive sleep apnea is provided. The valve structure is connected to an air flow generator and connected to a mask that covers at least the nostrils of a patient. The valve structure includes an inlet pressure port attached to the air flow generator and an expiration valve that includes an expiratory membrane, a primary seat and a secondary seat. During inspiration the expiratory membrane forms a seal with the primary seat, and during expiration the expiratory membrane forms a seal with the secondary seat.

The opening pressure of the expiratory valve may be variable and dependent on the pressure of air in the inlet pressure port as follows: (1) the opening pressure of the expiration valve increases when the pressure of air in the inlet pressure port increases; and/or (2) the opening pressure of the expiration valve decreases when the pressure of air in the inlet pressure port decreases.

The expiratory valve may have a standoff.

The valve structure may also include an inspiration valve constructed to allow air flow from the outside of the mask into the mask with little resistance and block air flow from within the mask to the outside of the mask. The inspiration valve and the expiration valve may be fluidly connected to an ambient port.

The valve structure may also have an inlet pressure valve that is constructed to allow air flow from the air flow generator into the mask with little resistance and block air flow from traveling from the mask to the air flow generator.

All of these valves may be part of a cartridge that is removable from the mask.

The valve structure may have an inspiration mode, a rest/apnea mode and an expiration mode. The inspiration mode occurs when the patient inspires air, during which the inspiration valve and the inlet pressure valve are open, and the expiratory membrane forms a seal with the primary seat. The rest/apnea mode occurs when the patient is neither inspiring air nor expiring air, during which the inlet pressure one-way-valve is open, the expiratory membrane forms a seal with the primary seat, and the inspiration valve is closed. The expiration mode occurs when the patient expires air, during which the expiratory membrane forms a seal with the secondary seat and the inlet pressure valve and the inspiration valve are closed.

The valve structure may have a disconnected mode when the air flow generator is not providing airflow to the valve structure: during which when a patient inspires, the inspiration valve opens and the expiratory membrane forms a seal with the primary seat. Additionally, during which when a patient expires, the inspiration valve is closed and the expiratory membrane forms a seal with the secondary seat.

The valve structure may be part of a larger system. The system may include a controller that delays the operation of the blower box, and/or gradually increases the amount of pressure delivered by the blower box.

A valve structure for treating a patient suffering from obstructive sleep apnea is provided. The valve structure is connected to an air flow generator and connected to a mask that covers at least the nostrils of a patient. The valve structure includes a housing with an inlet pressure port connected to the air flow generator, and an ambient pressure port. Within the housing is an expiratory membrane, an expiratory valve seat, an inspiratory membrane, an inlet pressure valve seat, an inspiratory valve seat, and an inspiratory membrane segmentation structure configured to segment the movement of the inspiratory membrane into at least a first portion and a second portion. An expiratory valve in fluid connection with the inlet pressure port is formed by the expiratory membrane and the expiratory valve seat. An inlet pressure valve is formed by the inlet pressure valve seat and the first portion of the inspiratory membrane, the inlet pressure valve allows air flow from the inlet pressure port into the mask with little resistance and blocks air flow from within the mask to the inlet pressure port. An inspiratory valve is formed by the inspiratory valve seat and the second portion of the inspiratory membrane, the inspiratory valve allows air flow from the ambient pressure port into the mask with little resistance and blocks air flow from within the mask to the ambient pressure port.

The expiratory valve seat and the inlet pressure valve seat may be integrally formed into the housing. The inspiratory membrane segmentation structure may further segment the movement of the inspiratory membrane into at least a third portion and a fourth portion. A second inlet pressure valve is formed by a second inlet pressure valve seat and the third portion of the inspiratory membrane. A second inspiratory valve is formed by a second inspiratory valve seat and the fourth portion of the inspiratory membrane. The second inlet pressure valve seat and the second inspiratory valve seat may be integrally formed into the housing.

The housing defines a housing center axis. The expiratory membrane is substantially planar and may be oriented substantially orthogonal to the housing center axis. Likewise, the inspiratory membrane is substantially planar and may be oriented substantially orthogonal to the housing center axis. The expiratory membrane may define an expiratory membrane center axis that is substantially coincident with the housing center axis. Likewise, the inspiratory membrane may define an inspiratory membrane center axis that is substantially coincident with the housing center axis.

The valve structure may have at least an inspiration mode, a rest/apnea mode and an expiration mode: the inspiration mode occurs when the patient inspires air, during which the inspiration valve and the inlet pressure valve are open, and the expiratory membrane forms a seal with the expiratory valve seat; the rest/apnea mode occurs when the patient is neither inspiring air nor expiring air, during which the inlet pressure valve is open, the expiratory membrane forms a seal with the expiratory valve seat, and the inspiration valve is closed; and the expiration mode occurs when the patient expires air, during which the expiratory valve is open and the inlet pressure valve and the inspiration valve are closed.

The valve structure may also have a disconnected mode when the air flow generator is not providing airflow to the valve structure: during which when a patient inspires the inspiration valve opens; and during which when a patient expires the inspiration valve is closed.

Additional aspects, alternatives and variations as would be apparent to persons of skill in the art are also disclosed herein and are specifically contemplated as included as part of the invention. The invention is set forth only in the claims as allowed by the patent office in this or related applications, and the following summary descriptions of certain examples are not in any way to limit, define or otherwise establish the scope of legal protection.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments are depicted in the accompanying drawings for illustrative purposes, and should in no way be interpreted as limiting the scope of the embodiments. Furthermore, various features of different disclosed embodiments can be combined to form additional embodiments, which are part of this disclosure. It will be understood that certain components and details may not appear in the figures to assist in more clearly describing the invention.

FIG. 1A is an exploded perspective view of an example PAP apparatus according to various example embodiments.

FIG. 1B is a front perspective view of an example valve cartridge adapted for use with the example PAP apparatus of FIG. 1A, according to various example embodiments.

FIG. 1C is a rear perspective view of the example valve cartridge of FIG. 1B according to various example embodiments.

FIG. 1D is a section side view taken through the middle of the example valve cartridge of FIG. 1B according to various example embodiments.

FIG. 1E is a front perspective section view of the example PAP apparatus of FIG. 1A, according to various example embodiments.

FIG. 1F is a rear perspective section view of the example PAP apparatus of FIG. 1A, according to various example embodiments.

FIG. 1G is a front perspective section view of the example PAP apparatus of FIG. 1A, depicted operating during the inspiration mode according to various example embodiments.

FIG. 1H is a rear perspective section view of the example PAP apparatus of FIG. 1A, depicted operating during the inspiration mode according to various example embodiments.

FIG. 1I is a section side view taken through the middle of the example valve cartridge of FIG. 1B, depicted operating during the inspiration mode according to various example embodiments.

FIG. 1J is a front perspective section view of the example PAP apparatus of FIG. 1A, depicted operating during the expiration mode according to various example embodiments.

FIG. 1K is a rear perspective section view of the example PAP apparatus of FIG. 1A, depicted operating during the expiration mode according to various example embodiments.

FIG. 1L is a section side view taken through the middle of the example valve cartridge of FIG. 1B, depicted operating during the expiration mode according to various example embodiments.

FIG. 1M is a front perspective section view of the example PAP apparatus of FIG. 1A, depicted operating during the rest/apnea mode according to various example embodiments.

FIG. 1N is a rear perspective section view of the example PAP apparatus of FIG. 1A, depicted operating during the rest/apnea mode according to various example embodiments.

FIG. 1O is a section side view taken through the middle of the example valve cartridge of FIG. 1B, depicted operating during the rest/apnea mode according to various example embodiments.

FIG. 2A illustrates a second embodiment of a novel sleep mask and valve structure for use in the treatment of sleep apnea.

FIG. 2B illustrates in an exploded view the various parts of the novel valve structure of FIG. 2A.

FIG. 2BB illustrates in an exploded view the various parts of a third embodiment of a novel valve structure for use in the treatment of sleep apnea.

FIG. 2C shows the fresh air flow and the blower air flow of the novel valve structure of FIG. 2A during inspiration.

FIG. 2D shows the fresh air flow and the blower air flow of the novel valve structure of FIG. 2A during inspiration.

FIG. 2E shows the blower air flow of the novel valve structure of FIG. 2A during inspiration.

FIG. 2F shows the fresh air flow of the novel valve structure of FIG. 2A during inspiration.

FIG. 2G shows the exhaled breath air flow of the novel valve structure of FIG. 2A during expiration.

Sleep Apnea Treatment System and Improvements Thereto

FIG. 2H shows the blower air flow of the novel valve structure of FIG. 2A during expiration.

FIG. 2I shows the blower air flow of the novel valve structure of FIG. 2A during expiration.

FIG. 2J shows the exhaled breath air flow of the novel valve structure of FIG. 2A during expiration.

FIG. 2K shows the blower air flow of the novel valve structure of FIG. 2A during apnea.

FIG. 2L shows the blower air flow of the novel valve structure of FIG. 2A during apnea.

FIG. 2M shows the fresh air flow and the blower air flow of the novel valve structure of FIG. 2A during inspiration.

FIG. 2N illustrates in an exploded view the various parts of the novel valve structure of FIG. 2A.

FIG. 3 illustrates the valve structures used as part of a larger system for treating a patient suffering from obstructive sleep apnea.

FIG. 4A is a schematic functionally depicting various aspects of an example PAP apparatus operating during the inspiration mode, according to various example embodiments.

FIG. 4B is a schematic functionally depicting various aspects of an example PAP apparatus operating during the expiration mode, according to various example embodiments.

FIG. 5 is a schematic functionally depicting various aspects of an example PAP apparatus operating during the rest/apnea mode, according to various example embodiments.

FIG. 6A is a schematic functionally depicting various aspects of an example PAP apparatus during inspiration when the blower is off (disconnect mode), according to various example embodiments.

FIG. 6B is a schematic functionally depicting various aspects of an example PAP apparatus during expiration when the blower is off (disconnect mode), according to various example embodiments.

FIG. 7A illustrates the response of the novel valve structure when an apnea event occurs during inspiration.

FIG. 7B illustrates the response of the novel valve structure when an apnea event occurs during expiration.

FIG. 7C illustrates the response of the novel valve structure when an apnea event occurs during mid-expiration.

FIG. 7D illustrates the response of the novel valve structure when an apnea event occurs during mid-inspiration.

FIG. 8 illustrates the flow path in the novel valve structure during an apnea event.

FIG. 9A illustrates the therapeutic pressure delivery of the novel valve structure for a tidal volume of 350 cc.

FIG. 9B illustrates the therapeutic pressure delivery of the novel valve structure for a tidal volume of 500 cc.

FIG. 10A illustrates a novel valve structure with a standoff, with no airflow.

FIG. 10B illustrates a novel valve structure with a standoff, during inhalation with pressurized airflow.

FIG. 10C illustrates a novel valve structure with a standoff, during expiration with pressurized airflow.

FIG. 10D illustrates a novel valve structure with a standoff, during an apnea event with pressurized airflow.

FIG. 10E illustrates the valve states for a novel valve structure with a standoff for the inspiration mode when blower box is disconnected.

FIG. 10F illustrates the valve states for a novel valve structure with a standoff for the expiration mode when blower box is disconnected.

FIG. 11 is a chart showing example pressures applied by an example PAP system at various times, according to various example embodiments.

FIG. 12 is a diagram depicting example relationships among example components of an example PAP system operated in part by a delay circuit, according to various example embodiments.

FIG. 13 is a diagram depicting example relationships among example components of an example PAP system operated in part by a sleep detector, according to various example embodiments.

DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

Reference is made herein to some specific examples of the present invention, including any best modes contemplated by the inventor for carrying out the invention. Examples of these specific embodiments are illustrated in the accompanying figures. While the invention is described in conjunction with these specific embodiments, it will be understood that it is not intended to limit the invention to the described or illustrated embodiments. To the contrary, it is intended to cover alternatives, modifications, and equivalents as may be included within the spirit and scope of the invention as defined by the appended claims.

In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. Particular example embodiments of the present invention may be implemented without some or all of these specific details. In other instances, process operations well known to persons of skill in the art have not been described in detail in order not to obscure unnecessarily the present invention. Various techniques and mechanisms of the present invention will sometimes be described in singular form for clarity. However, it should be noted that some embodiments include multiple iterations of a technique or multiple mechanisms unless noted otherwise. Similarly, various steps of the methods shown and described herein are not necessarily performed in the order indicated, or performed at all in certain embodiments. Accordingly, some implementations of the methods discussed herein may include more or fewer steps than those shown or described. Further, the techniques and mechanisms of the present invention will sometimes describe a connection, relationship or communication between two or more entities. It should be noted that a connection or relationship between entities does not necessarily mean a direct, unimpeded connection, as a variety of other entities or processes may reside or occur between any two entities. Consequently, an indicated connection does not necessarily mean a direct, unimpeded connection unless otherwise noted.

The following list of example features corresponds with FIGS. 1A-13 and is provided for ease of reference, where like reference numerals designate corresponding features throughout the specification and figures:

Sleep Mask 10

Nasal Pillow 15

Sleep Mask Valve Structure/Cartridge 20

Valve Housing 25

Expiratory Valve Seat 30

Expiratory Valve Membrane 35

Inlet pressure one-way valve Membrane 40

Inlet pressure one-way valve seat 42

Inspiratory one-way valve membranes 45A, B

Inspiratory one-way valve seat 47A, B

Inlet pressure port 50

Ambient Pressure Ports 55A, B

-   -   Valve Body connection structure 60     -   Cavity 65     -   Compliant/malleable nasal seat 70A, B     -   Positive pressure 75     -   Inspiration ambient air stream 80     -   Inspiration nasal air stream 85     -   Inspiration positive pressure air stream 90     -   Inspiration cavity pressure 93     -   Expiration nasal air stream 95     -   Expiration ambient air stream 100     -   Expiration positive pressure air stream 105     -   Expiration cavity pressure 106     -   Apnea positive pressure air stream 107     -   Apnea nasal air stream 108     -   Apnea cavity pressure 109     -   Sleep Mask 110     -   Sleep Mask Valve Structure/Cartridge 115     -   Sleep Mask Valve Structure/Cartridge Improved Design 115A     -   Inlet Pressure Port 116     -   Ambient Pressure Port 117     -   Valve Housing 120     -   Valve Housing center Axis 120A     -   Inspiratory Valve Seat 122     -   Second Inspiratory Valve Seat 122A     -   Inlet Pressure Valve Seat 122B     -   Second Inlet Pressure Valve Seat 122C     -   Expiratory Valve Seat 123     -   Expiratory Valve Membrane 125     -   Expiratory Valve Retaining Seat 130     -   Inspiratory Valve Retailing Seat 135     -   Inspiratory Membrane 140     -   First Segmented Portion of Inspiratory Membrane 140A     -   Second Segmented Portion of Inspiratory Membrane 140B     -   Third Segmented Portion of Inspiratory Membrane 140C     -   Fourth Segmented Portion of Inspiratory Membrane 140D     -   Retaining Clip 141     -   Intra-mask Side 142     -   Outside-mask Side 143     -   Outer Mask Baffling Screen 150     -   Intra-mask Baffling Screen 155     -   Inhaled Fresh Air 160     -   Blower Air 165     -   Patient Exhaled Breath 170     -   Blower Box 180     -   Tube 185     -   Non-positive pressure inspiration nasal air flow 220     -   Non-positive pressure inspiration ambient air flow 230     -   Non-positive pressure expiration nasal air flow 240     -   Non-positive pressure expiration ambient air flow 250     -   Apnea region 260     -   Valve Structure with Standoff 305     -   Standoff 310     -   Secondary Valve Seat 320     -   Inspiratory Valves 330     -   Pressurized Inspiratory Valve 340     -   Expiratory Membrane 350     -   Pressurized Air From Blower 360     -   Primary Valve Seat 370.     -   Pressurized Air From Patient 375     -   Small Opening/Intended Leak 385     -   Pressurize Air Flow Path From Blower 390     -   Air Flow Generator 400     -   Controller 410     -   Delay Circuit 420     -   Initiation Control 440     -   Transceiver 450     -   Sleep Detector 460     -   Conventional positive operation region 465     -   Positive air pressure of zero while user is falling asleep 470     -   Operation region of sleep apnea device 475     -   Increase of positive air pressure after the user falls asleep         480     -   FIGS. 1A through 1O provide a first embodiment of a sleep mask         10, comprising a unitary nasal pillow 15 configured to be         connected to a source of pressurized air, such as a conventional         PAP blower box (not shown) via a small-diameter single-lumen         hose (now shown). Nasal pillow 15 may be configured to be         sealably affixed to the nostrils of a user with         compliant/malleable nasal seats 70A, 70B (FIG. 4A) and held in         place by adjustable headgear (not shown). Nasal pillow 15 may be         formed from any appropriate material, such as silicone.     -   Nasal pillow 15 may be configured to removably receive therein a         centrally-located sleep mask valve structure/cartridge 20, for         instance partially or entirely within a sealed internal cavity         65 of nasal pillow 15 (FIGS. 1E, 1F), such that the valve         cartridge is removably located almost entirely or entirely         inside the exterior profile of the nasal pillow. Sleep mask         valve structure/cartridge 20 may in various example embodiments         be a unitary cylindrical assembly comprising a valve housing 25         defining an inlet pressure port 50 configured to removably         attach with the hose (not shown) communicating pressured air 90         from the PAP blower box (not shown). Valve housing 25 may         further define ambient pressure ports 55A, 55B, which may be         crescent-shaped and located adjacent and on opposite sides of         inlet pressure port 50. Ambient pressure ports 55A, 55B may be         configured to be in communication with ambient air 80 in the         room where the sleep mask 10 is being used.     -   One or more flexible expiratory valve membranes 35 (e.g., a         distensible or morphable soft membrane, such as a thin sheet of         10 Shore A silicone) may be removably assembled between the         valve housing 25 and one or more mating expiratory valve seats         30, for instance by a valve body connection structure 60 (such         as a compression-fit or snap-together mechanism 60), such that         in use each valve membrane 35 is exposed on one side (distal         expiratory valve seat 30) to pressured air 90 communicated         through inlet pressure port 50, and is exposed on the opposite         side (proximate expiratory valve seat 30) to expiration nasal         air stream 95. Expiratory valve membranes 35 may be formed from         a distensible or morphable soft membrane, such as a thin sheet         of 10 Shore A silicone, which creates a quiet, effective, and         robust seal that tends to effectuate a seal even in the presence         of minor debris, lint, and residue.     -   Valve housing 25 may further comprise one or more inlet pressure         one-way valve membranes 40 that in use are exposed on one side         to pressured air 90 communicated through inlet pressure port 50,         and are exposed on the opposite side to expiration nasal air         stream 95. One-way valve membranes 40 may be configured to open         and allow pressured air 90 to flow from inlet pressure port 50         into cavity 65 of nasal pillow 15 when pressured air 90 is at a         higher pressure than expiration nasal air stream 95. Conversely,         one-way valve membranes 40 may be configured to close and seal         against inlet pressure one-way valve seat 42 formed in valve         housing body 25 to prevent air flow between inlet pressure port         50 and cavity 65 when pressured air 90 is not at a higher         pressure than expiration nasal air stream 95.     -   Valve housing 25 may also comprise one or more inspiratory         one-way valve membranes 45A, 45B, configured such that in use         each inspiratory one-way valve membrane 45A, 45B is exposed on         one side (proximate ambient pressure ports 55A, 55B,         respectively) to ambient air 80 communicated through ambient         pressure ports 55A, 55B, respectively, and is exposed on the         opposite side (distal ambient pressure ports 55A, 55B,         respectively) to expiration nasal air stream 95. Inspiratory         one-way valve membranes 45A, 45B may be configured to open and         allow ambient air 80 to flow from ambient pressure ports 55A,         55B, respectively, into cavity 65 of nasal pillow 15 when         ambient air 80 is at a higher pressure than expiration nasal air         stream 95. Conversely, one-way valve membranes 40 may be         configured to close and seal against inspiratory one-way valve         seats 47A, 47B, formed in valve housing 25 to prevent air flow         between ambient pressure ports 55A, 55B, and cavity 65 when         ambient air 80 is not at a higher pressure than expiration nasal         air stream 95. The expiratory valve 35 and inspiratory valves         45A, 45B, share the same ambient pressure ports 55A, 55B, such         that the device is simple to manufacture and easy for the user         to clean. Also, the example design shown in the figures includes         no dead-end cavities or difficult-to-access recesses in the air         flow channels, which allows a user to clean and dry the device         effectively without leaving moisture that might bread mold or         mildew.     -   An example sleep mask 10 will now be described in use as part of         a system, according to various example embodiments. The nasal         pillow 15 may be connected with a traditional PAP blower box         (not shown) via a hose (not shown). The nasal pillow 15 may be         affixed to the nostrils of a user (not shown) via a silicone or         similar nasal interface 70A, 70B, and adjustable headgear (not         shown). The function of the nasal pillow 15 may be described by         three distinct modes: inspiration, expiration, and rest/apnea,         depicted in FIGS. 4A, 4B, 5, respectively (where only one         inspiratory one-way valve membrane and seat are shown) and again         at FIGS. 1G-1I, 1J-1L, and 1M-1O respectively (where two         inspiratory one-way valve membranes and seats are shown).     -   A second embodiment is shown in FIGS. 2A and 2B. The sleep mask         110 contains a sleep mask valve structure/cartridge 115 that is         comprised of a ridge or semi-rigid valve housing 120, expiratory         valve membrane 125, an expiratory valve retaining seat 130, and         inspiratory valve seat 125, an inspiratory valve membrane 140         and a retaining clip 145. The inspiratory valve membrane 140 and         expiratory valve membrane may be formed from a sound absorbing         material, such as an elastomer. To further mitigate sound, the         valve housing 120 may include a sound absorbing liner, made of a         material with a preferred durometer of 50 A to 90 A.     -   The valve housing 120 also forms an inspiratory valve seat 122,         that in combination with the inspiratory valve membrane 140         creates a one-way valve. Further, the valve has an inlet         pressure valve seat 122B that uses the same inspiratory valve         membrane 140 creating a one-way valve inlet pressure valve; but         the membrane action is segmented by use of the retaining clip         145. The valve housing 120 also forms an expiratory valve seat         123 that forms a variable resistance expiratory valve, that can         be adjusted based on the pressure of the blower air. The sleep         mask valve structure/cartridge 115 has an intra-mask side 142         that is proximal (as a function of air path) to the patient and         an outside-mask side 143 that is distal to the patient.     -   Pressurized air is delivered to the valve structure/cartridge         115 through the inlet pressure port 116. Air exhausted through         expiration or inhaled through inspiration may travel through the         ambient pressure port 117.     -   The operation of this sleep mask valve structure/cartridge 115         is shown in FIGS. 2C-2L. Specifically, FIGS. 2C-2F illustrate         the inspiration mode and in particular the flow paths of the         inhaled fresh air 160 and the blower air 165. The fresh air 160         moves into the valve structure/cartridge 115 through the ambient         pressure port 117 and unseats the inspiratory membrane 140 from         the inspiratory valve seat 122 allowing fresh air 160 to enter         the mask. The blower air 160 moves into the valve         structure/cartridge 115 through the inlet pressure port 116 and         unseats the inspiratory membrane 140 from the inlet pressure         valve seat 122B allowing blower air 160 to enter the mask. (see         FIG. 2C). The retaining clip 145 segments the action of the         inspiratory membrane 140, forming two inspiratory valves and two         inlet pressure valves. The valve structure/cartridge 115 and         housing 120 therefore define inspiratory airflow conduit (shown         by the airflow movement arrows in FIGS. 2C-2F) accommodating         airflow from the outside mask side 143 to the intra-mask side         142. This dual purpose use of the inspiratory membrane 140         allows for fewer parts in the final construction, easing         manufacturing and reducing costs.     -   FIG. 2G-2J illustrates the expiration mode and the flow paths of         the blower air 165 and the patient's exhaled breath 170. In the         expiration mode the blower air 165 applies a pressure against         the expiratory valve membrane 125. This resistance can assist in         preventing an apnea event. The valve structure/cartridge 115 and         housing 120 therefore define expiratory airflow conduit (shown         by the exhaled breath 170 in FIGS. 2G-2J) accommodating airflow         from the intra-mask side 142 to the outside mask side 143. The         exhaled breath 170 exits the valve structure/cartridge 115         through the ambient pressure port 117.     -   FIGS. 2K-2L illustrate the apnea mode of the valve structure,         with the blower air 165 applying a pressure against the         expiratory valve membrane 125 while simultaneously providing a         positive pressure of air to the patient, thus offering a         therapeutic pneumatic splint that maintains the patient's airway         open preventing an apnea event.     -   FIGS. 2M and 2N illustrate the simplicity of the radial design         that uses a single inspiratory membrane 140 with a clip 145 that         acts as inspiratory membrane segmentation structure that         segments the movement of the inspiratory membrane 140.         Specifically, the clip 145 segments the movement into a first         portion 140A, a second portion 140B, a third portion 140C and a         fourth portion 140D. The valve housing 120 has an inlet pressure         port 116 and an ambient pressure port 117. Within the housing         120 is the expiratory membrane 125, an expiratory valve seat         123, an inspiratory membrane 140, an inlet pressure valve seat         122B, an inspiratory valve seat 122, and the clip 145 (i.e., an         inspiratory membrane segmentation structure configured to         segment the movement of the inspiratory membrane). An expiratory         valve in fluid connection with the inlet pressure port is formed         by the expiratory membrane 125 and the expiratory valve seat         123. An inlet pressure valve is formed by the inlet pressure         valve seat 122B and the first portion of the inspiratory         membrane 140A. The inlet pressure valve is constructed to allow         air flow 165 from the inlet pressure port 116 (connected to the         blower) into the mask with little resistance and block air flow         from within the mask out. An inspiratory valve is formed by         inspiratory valve seat 122 and the second portion of the         inspiratory membrane 140B. The inspiratory valve is constructed         to allow air flow from the ambient pressure port 117 into the         mask with little resistance and block air flow from within the         mask out. A second inlet pressure valve is formed by the second         inlet pressure valve seat 122C and the third portion of the         inspiratory membrane 140C. A second inspiratory valve is formed         by the second inspiratory valve seat 122A, and the fourth         portion of the inspiratory membrane 140D. As shown in FIG. 2N,         the inspiratory valve seats 122, 122A and the inlet pressure         valve seats 122B, 122C can be integrally formed in the housing         120. The housing 120 may define a housing center axis 120A. The         expiratory membrane 125 is substantially planar and may be         oriented substantially orthogonal to the housing center axis         120A. Likewise, the inspiratory membrane 140 is substantially         planar and may be oriented substantially orthogonal to the         housing center axis.     -   The expiratory membrane 125 may define an expiratory membrane         center axis that is orthogonal to the plane defined by the         expiratory membrane 125 and is substantially coincident with the         housing center axis 120A. Likewise, the inspiratory membrane 140         may define an inspiratory membrane center axis that is         orthogonal to the plane defined by the inspiratory membrane 145         and is substantially coincident with the housing center axis         120A.     -   FIG. 3 illustrates the valve structures used as part of a larger         system, which includes a blower box 180, a tube 185 connected to         a mask (10, 110). The unique design of the valve structures         discussed herein allows the supplied air and the valve         controlling air to be combined into a single hose with a single         lumen. This has unique advantages, in that the hose can be         smaller, more supple (an important user feature is not having a         cumbersome hose to distract from sleeping), easier to clean (the         system need not have any elongated, small lumens that end in a         closed compartment in the valve resistance generating chamber),         and easier to connect as only a single orientation independent         hub is needed at either end. For example, an outer diameter of         the hose can be between about 3.0 mm and about 15.0 mm. In some         embodiments, an inner diameter of those hoses can be less than         or equal to about 10.0 mm, e.g., between about 5.0 mm and about         10.0 mm. In some embodiments, a wall thickness of those hoses         can be less than or equal to about 1.0 mm, e.g., between about         0.5 mm and about 0.75 mm. The smaller hose is less bulky than         traditional hoses for CPAP devices. Such a hose is described in         U.S. patent application Ser. No. 14/278587 filed on May 15,         2014, 62/246477 filed on Oct. 26, 2015 and 62/694126 filed on         Jul. 5, 2018, the contents of which are incorporated by         reference in their entireties.     -   In various example embodiments discussed, the valve         structure/cartridge may have three modes: inspiration,         expiration and rest/apnea. In operation, the valve structure is         connected to a mask and properly affixed to a patient. The         blower box is set to the user's prescribed pressure, e.g., 0-20         cm H₂O. The blower box may immediately apply this pressure, or         as discussed below the pressure may be delayed and graduated.     -   The device mode of “inspiration” starts when the user inhales,         as depicted in FIGS. 4A, 1G-1I and 2C-2F. As the user inhales,         inlet pressure one-way valve membrane (40, 140) and inspiratory         one-way valve membranes (45A, 45B, 140) open and both ambient         room air (80,160) and pressurized blower air (90,165) enter the         mask at an inspiration cavity pressure 93, and that air flows         through nasal interface 70A, 70B to the user as inspiration         nasal air stream 85. Inspiration also causes the pressurized         blower air (90, 165) to create a net positive pressure 75 over         the expiratory valve membrane (35, 125), causing it to sealably         close against the expiratory valve seat (30, 123). Since the         expiratory valve membrane (35, 125), may be formed from a soft,         flexible, compliant material, it advantageously makes little to         no noise when it moves and engages and disengages the valve seat         (30, 123). This helps the user go to sleep and increases         effectiveness by increasing user compliance with usage regimens.     -   As depicted in FIG. 4A, the expiratory valve membrane (35, 125)         is sealably closed against expiratory valve seat (30, 123)         because of a net force differential across the expiratory valve         membrane (35, 125) in the direction of positive pressure 75, but         only when the expiratory valve membrane (35, 125) is closed         against seat (30, 123), as shown in FIGS. 4B and 5. Once the         expiratory valve membrane (35, 125) is closed against seat (30,         123), this net force differential tends to bias expiratory valve         membrane (35, 125) closed against seat (30, 123) until the         pressure in the cavity 65 increases above the pressure of blower         air (90, 165). At which time the expiratory valve membrane (35,         125) begins to open and unseat from seat (30, 123), causing the         expiratory valve membrane (35, 125) to open.     -   After inspiration, the user will begin to exhale. The state of         expiration starts when the user exhales, as depicted in FIGS.         4B, 1J-1L and 2G-2J. Exhalation causes the pressure inside the         mask to rise up to and slightly higher than the blower box         setting, thereby causing the inlet pressure one-way valve         membrane (40, 140) and inspiratory one-way valve membranes (45A,         45B, 140) to close. With the inlet pressure one-way valve         membrane (40, 140) closed, an expiration positive pressure air         stream 105 builds pressure in the inlet pressure port (50, 116).         This pressurized air 105 applies a force to the expiratory valve         membrane (35, 125), urging it toward the expiratory valve seat         (30, 123), and sealing it against the expiratory valve seat (30,         123) until the expiration nasal air stream 95 builds up enough         pressure in the cavity 65 to overcome the force of pressurized         air 105 and unseat expiratory valve membrane (35, 125) from         expiratory valve seat 30, thereby permitting the user to exhale,         via open expiration ambient air stream 100 flowing out into the         room through ambient pressure ports (55A, 55B, 117). This is how         the present system governs the expiration cavity pressure 106;         i.e., it is a direct and passive function of the amount of         blower pressure 105. Accordingly, a blower set at different         pressure settings will pressurize the expiratory valve membrane         (35, 125) to different resistances. A lower blower box setting         results in a lower resistance to unseating expiratory valve         membrane (35, 125) from expiratory valve seat (30, 123), and         thus causes a lower expiration cavity pressure 106. A higher         blower box setting results in a higher resistance to unseating         expiratory valve membrane (35, 125) from expiratory valve seat         (30, 123), and thus causes a higher expiratory cavity pressure         106. This unitary nasal pillow 15 system can thus automatically         and passively react to a multitude of blower box pressure         settings. It also is contemplated that the nasal pillow 15 can         react to real-time changes in the blower box pressure setting.         For example, if the blower box has ramps, pressure relief, or         dynamically titrates pressure, the nasal pillow 15 should be         able to instantly react appropriately.     -   If the user is sleeping normally, the user will finish         exhalation and begin a new inhalation breath.     -   However, if either inspiration or expiration is stopped, for         instance by apnea, the nasal pillow 15 will automatically enter         into rest/apnea mode as depicted in FIGS. 5, 1M-1O and 2K-2I. In         this state the user is neither inhaling nor exhaling, so the         expiratory valve membrane (35, 125) is sealably seated against         expiratory valve seat (30, 123) by apnea positive pressure air         stream 107 in the inlet pressure port (50, 116). Apnea positive         pressure air stream 107 quickly builds up in the inlet pressure         port (50, 116) to a higher pressure than the initial apnea         cavity pressure 109 in the cavity 65, causing the inlet pressure         one-way valve membrane (40, 140) to open, thereby pressurizing         the cavity 65 and causing inspiratory one-way valve membranes         (45A, 45B, 140) to close. Air from the blower 107 then builds up         pressure 109 in the interior 65 of the nasal pillow 15 to the         pressure set at the blower box. The pressure 109 inside the         pillow 15 will then splint the user's airway, and the air from         the blower box will flow through nasal interface 70A, 70B to the         user as apnea nasal air stream 108, allowing the user to return         back to breathing. Notably, only a minimal air flow is required         from the hose, just enough to achieve a “dead-headed” pressure         of the blower box or a minimal flow necessary to achieve         pressure and make up for any small system leaks.     -   Since the present system is so sensitive and quick-reacting, in         certain applications it may be appropriate to use it with a         blower or airflow generator that need not run continuously, but         rather is only activated as needed, for instance immediately         upon detection of OSA. This option is possible with the present         system in part because its unique valving system provides the         additional feature of allowing a user to breathe normally while         wearing it when there is no airflow or pressure being provided         to the inlet port (50, 116) by a blower—i.e., the disconnect         mode. This is demonstrated in FIGS. 6A and 6B, which show that         when there is no airflow or pressure being provided to the inlet         port (50, 116) by a blower, the expiratory valve membrane (35,         125) will automatically move to its neutral position, which is         unseated from the expiratory valve seat (30, 123), thereby         opening a breathing path for the user. Specifically, upon         inspiration, non-positive pressure inspiration ambient air flow         230 may travel through ambient pressure ports (55A, 55B, 117),         providing the user with non-positive pressure inspiration nasal         air flow 220. Further facilitating inspiration, inspiratory         one-way valve membranes (45A, 45B, 140) will open upon         inhalation, providing increased non-positive pressure         inspiration ambient air flow 230 through ambient pressure ports         (55A, 55B, 117), thus providing the user with increased         non-positive pressure inspiration nasal air flow 220. It is also         possible that, depending on the pressure in the cavity and the         construction of the expiratory valve membrane (35, 125), that         the expiratory valve member (35, 125) may seat with the         expiratory valve seat (30, 123) during inhalation, thus all         airflow would travel through the ambient pressure ports (55A,         55B, 117) and through the inspiratory one-way valves. And upon         expiration, non-positive pressure expiration ambient air flow         250 may travel past the open expiratory valve membrane (35, 130)         and through ambient pressure ports (55A, 55B, 117), providing         the user with non-positive pressure expiration nasal air flow         240.     -   FIG. 7A captures the pressure response of the valve structures         disclosed herein if the cessation of breathing occurs during         inspiration, or during a “pause” between inspiration and         expiration. The apnea region 260 represents the moment at which         the simulated apnea begins. Likewise, FIGS. 7B, 7C and 7D         captures the pressure response for an apnea during expiration,         mid-expiration and mid-inspiration, respectively.     -   FIGS. 7A-7D illustrate the valve response to incipient apnea at         various stages of the breathing cycle. In these simulations, the         flow generator pressure was set to 12 cm H2O and the respirator         was set to 500 cc tidal volume at 15 breaths per minute with an         inspiratory: expiratory ratio of 1:3. These figures confirm that         the system response is immediate and not dependent on the         precise point within the respiratory cycle that an apnea occurs.         Within less than a second, more precisely within less than a         quarter of a second (shown most clearly in FIGS. 7B and 7D), the         valve structures can reach therapeutic pressure from ambient         pressure. And again, the valves can reach this pressure,         regardless of when in the breathing cycle the apnea event         occurs.     -   The testing shown in FIGS. 7A-7D was performed on the second         embodiment valve structure (i.e., FIG. 2B). The dual inspiration         valves that are connected to the blower box allow a sufficient         amount of pressurized air to enter the mask quickly, providing         therapeutic pressure to the patient almost instantaneously after         the onset of an apnea event. Further, the inspiratory membrane         140 for both inspiratory valves is perpendicular to the channel         formed by the valve housing 120, such that the pressurized air         can enter the mask in sufficient volume with a slight bend in         the direction of flow, as shown in FIG. 8. This promotes more         laminar and less restricted flow, which allows for         near-instantaneous pressurization of the mask.     -   The design of the valve structure is also robust in that it can         be used with all patients, regardless of breathing rate or per         breath volume. For example, as shown in FIG. 9A the valve is         subjected to 15 breaths/minute with a tidal volume of 350 cc.         The valve structure can maintain the set therapeutic pressure of         12 cm of H₂O throughout the breathing cycle. And as already         discussed, should the patient experience an apnea event, the         therapeutic pressure would be delivered to the mask nearly         instantaneously providing the therapeutic pneumatic splint that         maintains the patient's airway open reversing the apnea event.         The same mask can provide therapeutic pressure for a different         patient with, for example, 10.5 breaths/minute with a tidal         volume of 500 cc as shown in FIG. 9B. In spite of a nearly 50%         increase in tidal volume, the valve structure still maintains         therapeutic pressure. While these are just two examples, the         valve structure can accommodate tidal volumes ranging from 0 to         800 cc, with breath/minute ranging from 0 to 18. These ranges         will accommodate nearly every patient suffering from sleep         apnea. Moreover, while the therapeutic pressure shown in FIGS.         7A-7D and 9A-9B is 12 cm of H₂O, the pressure is fully         adjustable and may be increase or decreased. The performance of         the valve structure, including the near-instantaneous         pressurization is not affected by the set therapeutic pressure.     -   Now a novel standoff feature will be described. It would be         desirable to reduce the sensation of the expiratory valve         opening. Additionally it would be useful to reduce pressure         during expiration to provide a comfort benefit to the user. By         adding a standoff feature in the valve to prevent the membrane         from fully forming convex during exhalation. The standoff would         allow the distensible membrane to fully form a concave state         against the vent valve seat, but would not allow the membrane to         fully flex convex during exhalation. Further the standoff would         form a secondary valve seat. FIGS. 10A-10F illustrate the valve         structure with the standoff. The dashed arrows in these figures         denote air flow movement.     -   Referring to FIG. 10A, the valve structure 305 has a standoff         310 that forms a secondary valve seat 320. The valve structure         305 has similar inspiratory valves 330 as well as the         pressurized inlet valve 340 as in the previously described         embodiments. Those valves operate similar to the embodiments         already described in the inspiratory, expiratory and rest/apnea         modes. The standoff 310, however, affects the operation of the         expiratory valve and makes it easier for the patient to open the         expiratory valve—increasing patient comfort and reducing noise.         FIG. 10B illustrates the valve structure 305 when the blower is         on providing pressurize air. This is the inhalation phase, and         the pressurized air from the blower is acting on the entire         underside of the expiratory membrane 350, as shown by pressure         arrows 360. Also, the membrane 350 forms the seal using the         primary valve seat 370.     -   FIG. 10C is the expiratory phase when the blower providing         pressurized air. The patient provides the pressure needed to         open the expiratory valve as shown by pressure arrows 375, but         the valve now seals on the secondary valve seat 320. On the         opposite side of the expiatory membrane is the pressure exert by         the blower air, shown by pressure arrows 360. What is important         to note is that the pressure exerted by the patient is over a         much larger area of the expiratory membrane than the area over         which the pressure from the blower exerts. This means that once         the expiratory valve is sealed it takes less pressure than the         blower box is providing to keep the expiratory valve sealed. To         further assist the complete seal during the expiratory phase,         the valve structure 305 may have a small opening 385 that allows         a small intended leak so that the volume on the opposing side of         the expiratory membrane from the patient can be depressurized.     -   Having a dual seat structure for the expiratory valve increases         the patient comfort. Specifically, when a patient begins the         expiratory phase of breathing, it is generally with a pressure         and volume that is initially high and then tapers off some         during expiration.     -   Without a dual seat design, a patient might initially have         sufficient expiration to open the expiratory valve, but as the         expiratory phase continues the expiration tapers potentially to         a point where there is an insufficient force to keep the         expiratory valve opened. This would therefore cut-off the         natural expiratory phase of the breathing cycle and cause         discomfort for the patient.     -   With the dual seat design, the initial force of the expiration         opens the expiratory valve and seals the valve on the secondary         seat formed by the standoff. As the expiration tapers off, there         remains sufficient pressure to keep the valve sealed against the         secondary seat until the patient naturally pauses in breathe to         being the inhalation phase. This is much more comfortable for         the patient.     -   FIG. 10D illustrates the valve structure 305 during an apnea         event. Its operation is similar to those discussed above with         arrow 390 showing the path of the pressured air.     -   Finally FIGS. 10E and 10F illustrate the valve states for the         inspiration and expiration when the blower box is disconnected.     -   As with the embodiments discussed above, the design of valve         structure 305 allows for near instantaneous pressurization         during an apnea event, regardless when in the respiration cycle         the event occurs. And the same valve structure is robust enough         to be used across a wide range of tidal volumes and         breaths/minute.     -   Since the present the nasal pillow/mask 15 does not require the         blower to run continuously, in various example embodiments a PAP         blower may be initiated in response to a preset delay, or in         response to a detected onset of sleep or attainment of a         preselected sleep stage, to enable a user to fall asleep while         the blower is off. Accordingly, various example aspects of an         airflow generator with delayed onset will now be described with         reference to FIGS. 14-16.     -   Currently, human sleep stages are typically determined using a         laboratory-based measurement called polysomnography. In         polysomnography, it is typical for several electroencephalogram         readings to be taken (EEGs are the microvolt potentials         generated by brain activity that can be measured at the scalp         using electrodes), in addition to other parameters such as         respiration, electrocardiogram (ECG), leg movements, and         electro-oculograms (EGG). Based on work originally pioneered by         Rechtschaffen and Kales (R&K), it is now conventional to score         human sleep in 30-second epochs, and to label these epochs using         sleep stage labels.     -   At present, the American Academy of Sleep Medicine defines the         stages of sleep as:

-   Wake—this is when a person is fully awake, and is characterized by a     positive dominant rhythm in the occipital EEG channel (when eyes are     closed), typically in the range 8-14 Hz (often referred to as alpha     waves).

-   Stage N1—this is the lightest stage of sleep, and is characterized     by the appearance of some low amplitude waves at multiple     frequencies interspersed with the alpha waves for more than 50% of     an epoch. There may also be sharp vertex waves, some slow eye     movements on the EGG and/or an overall lowering of the frequency of     EEG.

-   Stage N2—this is a slightly deeper stage of sleep, and is marked by     the appearance of sleep spindles and K-complexes, on a background of     mixed frequency signals. Sleep spindles are bursts of higher     frequency activity (e.g., greater than 12 Hz). K-complexes are     distinct isolated bipolar waves lasting about 1-2 seconds.

-   Stage N3 is the deepest stage of sleep (in the original R&K     classification, there were two distinct stages called Stage 3 and     Stage 4). This is characterized by the appearance of slow waves     (e.g., 1-2 Hz frequency) for at least 20% of an epoch.

-   Stage R (REM)—this is rapid eye movement sleep, and is apparent     through the presence of distinct activity in the EOG signal. The EEG     signals recorded are typically quite similar to Stage N1 or even     wake.     -   An automated system for scoring polysomnogram data is described         in U.S. Pat. No. 5,732,696 to Rapoport et al., which is         incorporated herein by reference. The system uses a computer to         look for elemental patterns in the PSG data (such as the sleep         spindles described above), and then uses a probabilistic         weighting to score each epoch. However this approach to the         problem of determining sleep stages is limited by the technical         difficulty of measurement of a full set of polysomnogram         signals, and hence is difficult and cumbersome to implement for         more than a single night.     -   A number of systems have provided alternative techniques for         determining sleep stage. One approach is to use actigraphy, in         which small motion sensors (e.g., accelerometers) are worn by a         user, typically in a wristwatch configuration in some cases         referred to as activity trackers. Such systems may be able to         effectively distinguish between sleep and wake, but may not         effectively distinguish between different sleep states.     -   US2006/0184056 (Heneghan et al.), which is incorporated herein         by reference, describes a sleep monitoring system which uses an         ECG signal which is processed to determine a status for each         epoch, either apneic or normal.     -   WO2007143535 (Heneghan et al.), which is incorporated herein by         reference, describes a system for monitoring physiological signs         such as sleep state by monitoring motion, breathing, and heart         rate signals obtained in a non-contact fashion. A classifier         model is applied to the streams of data.     -   A system which combines ECG and respiration methods to determine         a simplified sleep stage is described in US20090131803 (Heneghan         et al.), which is incorporated herein by reference. This         combines signal characteristics derived from cardiogram and         respiration signals, such as the amplitude modulation of the ECG         signal and the dominant respiratory frequency in order to         distinguish sleep from wakefulness.     -   WO2004112606 (Heneghan et al.), which is incorporated herein by         reference, describes a method of detecting sleep apnea using         trans-cervical bioimpedance measurements.     -   US2011/0124979 (Heneghan et al.), which is incorporated herein         by reference, describes an approach to sleep monitoring using         ECG and photoplethysmogram (PPG) data. These may be sensed using         a Holter monitor and a pulse oximeter which are wearable in an         ambulatory manner.     -   An approach in which cardiac R-R wave intervals are used to         designate sleep as REM or non-REM is described in U.S. Pat. No.         5,280,791 to Lavie, which is incorporated herein by reference. A         power spectrum of the cardiac R-R interval is calculated in         order to determine the stages of sleep.     -   US2014/0088373 (Phillips et al.), which is incorporated herein         by reference, discloses a system that is said to be able to         differentiate between sleep states. A processor determines a         sleep stage based on a combination of bodily movement and         respiration variability. The determination of sleep stages may         distinguish between deep sleep and other stages of sleep, or may         differentiate between deep sleep, light sleep and REM sleep. The         bodily movement and respiration movement signals may be derived         from one or more sensors, such as a non-invasive sensor (e.g., a         non-contact radio-frequency motion sensor or a pressure         sensitive mattress).     -   Any of a variety of commercially available wearable or portable         activity trackers are also equipped with sleep detection         capabilities, such as: FIT BIT (Fitbit Inc. 405 Howard Street,         San Francisco, Calif. 94105); SENSE and SLEEP PILL (Hello Inc,         1660 17th Street, San Francisco, Calif. 94107); Beddit (Misfit);         MisfitShine (Misfit); and Withings Aura™ for example.     -   Conventional breathing devices such as CPAP systems must have         the blower operating while the user is wearing the mask. The         blower is typically set to a minimum of 4 cm H₂O. This is         necessary because without the blower delivering fresh air, the         user re-breaths residual exhalations that migrate into and out         of the hose. The blower is not continuously flushing out the         stale air from the hose when turned off in conventional CPAP.         The blower creates noise and perceptible air flow, interfering         with the wearer's ability to go to sleep.     -   The system of the present invention eliminates the need for the         blower to operate while the user is attempting to go to sleep.         It may also have a much smaller caliber hose, such as 50%         smaller in diameter. This has a significant volume reduction,         hence significantly less potential for “re-breath air” to         reside. Also, a preferred embodiment has a one-way flapper valve         on the air supply path which prevents exhaled breath from         migrating into the hose. While prior art systems need to         maintain around a minimum flow rate corresponding to 4 cm H₂O of         pressure while the user tries to go to sleep over the noise, the         blower in the system of the present invention can be shut off         while the user is trying to go to sleep. The blower is instead         not turned on until a delayed start time T. Time T can be         preselected as a delay from initiation of the clock and measured         in time such as in minutes or hours. Alternatively, T can be a         set time of day programmed in by the user or care giver, based         upon their experience how long it takes that user to go to         sleep, or a time at which the onset of sleep is detected using         any of a variety of sleep detectors.     -   Graphically, conventional systems must operate in the hashed         area 465 shown in FIG. 11, with an air flow of at least about 4         cm H₂O at all times that the mask is worn by the user, and         ramping to higher flow rates.     -   The present system operates on the datum line 470 and in the         hashed area 475 shown above the datum line 470. The air flow         rate from the blower can be zero while the user is awake, and         the blower can remain off until after the user has fallen         asleep. After the onset of a sleep state, the blower can turn on         and subsequently ramp up 480 to the desired therapeutic flow         rate. This is advantageous because it eliminates the sensation         of forced airflow, and eliminates noise from the blower box,         while the user is trying to go to sleep. Also, this preserves         the ability to speak naturally prior to sleep.     -   The present system can work with the blower off indefinitely. In         one embodiment the blower is off at the start of use and turns         on at a preset time delay following activation of the timing         cycle. The time delay can either be programmed into the machine         or selectable by the physician or user (an off time could also         be set for an anticipated wake-up). The user may select or input         a delay such as at least about 5 minutes, or at least about 10,         15, or 30 minutes, or up to an hour or more, for example. The         blower will automatically turn on at delayed start time T and         begin to ramp up in air flow when the preset delay period has         expired. Alternatively, the user can select a start time of day         such as 10:00 PM or 11:00 PM by which time the user expects to         be asleep.     -   Alternatively, the blower can turn on in response to a         determination that the user has fallen asleep or reached a         particular sleep stage. Sleep sensors may be employed to         determine when the user achieves a sleep state. In response to         the detection of the onset of sleep, the blower is turned on and         ramps to the desired therapeutic flow rate. The sleep sensors         may be carried by the system, or may be a remote device that is         in wireless or wired communication with the system. Any of the         sleep detection devices discussed elsewhere herein can be         utilized to determine the onset of sleep.     -   Thus, one or more biometric monitoring devices may automatically         detect or determine when the user is attempting to go to sleep,         is entering sleep, is asleep, and/or is awoken from a period of         sleep. In such embodiments, the biometric monitoring device may         employ physiological sensors to acquire data and the data         processing circuitry of the biometric monitoring device may         correlate a combination of heart rate, heart rate variability,         respiration rate, galvanic skin response, motion, skin         temperature, and/or body temperature data collected from sensors         of the biometric monitoring device to detect or determine if the         user is attempting to go to sleep, is entering sleep, is asleep,         and/or is awoken from a period of sleep. For example, a decrease         or cessation of user motion combined with a reduction in user         heart rate and/or a change in heart rate variability may         indicate that the user has fallen asleep. Subsequent changes in         heart rate variability and galvanic skin response may then be         used by the biometric monitoring device to determine transitions         of the user's sleep state between two or more stages of sleep         (for example, into lighter and/or deeper stages of sleep).         Motion by the user and/or an elevated heart rate and/or a change         in heart rate variability may be used by the biometric         monitoring device to determine that the user has awoken.         Additional details can be found in US patent publication         20140278229 to Hong, et al., assigned to Fitbit, Inc., the         disclosure of which is hereby incorporated in its entirety         herein by reference.     -   The PAP system of the present invention thus includes an input         for receiving a signal indicative of the onset of sleep or a         change in a stage of sleep. The input may be a wired port or a         wireless port. Preferably but not necessarily, a wireless port         is provided in the form of a transceiver for wireless pairing         with any of a variety of commercial devices capable of         determining sleep state.     -   These include any of a variety of commercial activity trackers         (e.g., Fitbit, Jawbone, Under Armour, UP, Resmed S+) or with a         sleep detection bed (e.g., Sleep Number) or with any of a         variety of dedicated sleep detection systems that can be either         integrated into the device or separate but connectable via         wireless or hard-wired connection.     -   In another embodiment sleep/apnea sensors are employed to turn         the machine on only when both sleep and apnea are occurring. In         either case, the sleep sensors could also do the opposite         function and turn the blower off when waking is sensed. Suitable         sleep apnea detection systems are disclosed in U.S. Patent         Publication No. 2014/0200474, the disclosure of which is         incorporated by reference in its entirety herein.     -   The advantages of being able to wear a PAP mask with no blower         operating include: comfort from force airflow while awake;         talking without the difficulty of forced air; less noise while         attempting to sleep; and reduction of wasted power, in         particular, battery power.     -   Referring to FIG. 12, the present system may comprise a         mask/hose and a blower box with an air flow generator 400, a         controller 410 and a delay circuit 420. An initiation control         440 is provided for the user to initiate a delay cycle. The         initiation control can be a button, switch, touch screen or         other control.     -   The present system has the ability to communicate with accessory         devices. This communication can come from mechanical or         pneumatic feedback, but preferably but not necessarily is         electronic communication transmitted over a wire or wireless.         Most preferably but not necessarily the present system has         “Bluetooth” or other wireless communication with accessory sleep         detection devices. The communication features could be in any         component, but most preferably but not necessarily is in the         blower box. Referring to FIG. 13, the controller 410 is in         electrical communication with a transceiver 450 which may be         permanently or removably carried by the housing as discussed         herein. The transceiver 450 can be paired into wireless         communication with a sleep detector 460.     -   The wireless communication module 450 and associated antenna         carried by the PAP device thus provide a wireless connection         between the CPAP device and a paired sleep detection device 260         such as any of those discussed herein. Preferably but not         necessarily the sleep detector is a wearable device such as an         activity tracker. Pairing may be accomplished utilizing any of a         variety of short-range wireless protocols appropriate for the         particular sleep detection device, such as Wi-Fi, Zigbee,         Bluetooth, wireless HDMI and/or IEEE 802.11 protocols (e.g.,         802.11G, 802.11N, 802.11AC, or the like). Other examples of         potential communication protocols include iBeacon, Z-Wave,         WirelessHART/Dust Networks, ISA 100a, ISM-band-based channels,         IMBI, ANT or ANT+, or other methods of communication.     -   For the purposes of the present disclosure, the term “ANT” is         intended to include “ANT+ and refers to a proprietary wireless         sensor network technology featuring a wireless communications         protocol stack that enables semiconductor radios operating in         the 2.4 GHz industrial, scientific, and medical allocation of         the RF spectrum (“ISM band”) to communicate by establishing         standard rules for co-existence, data representation, signaling,         authentication, and error detection. ANT is characterized by a         low computational overhead and low to medium efficiency,         resulting in low power consumption by the radios supporting the         protocol.     -   For the purposes of the present disclosure, the term         “Bluetooth®” refers to a wireless technology standard for         exchanging data over short distances (using short-wavelength         radio transmissions in the ISM band from 24000-2480 MHz) from         fixed and mobile devices, creating personal area networks (PANs)         with high levels of security. Created by telecom vendor Ericsson         in 1994, it was originally conceived as a wireless alternative         to RS-232 data cables. It can connect several devices,         overcoming problems of synchronization. Bluetooth® is managed by         the Bluetooth® Special Interest Group, which has more than 18,         000 member companies in the areas of telecommunication,         computing, networking, and consumer electronics. Bluetooth® was         standardized as IEEE 802.15.1, but the standard is no longer         maintained.     -   A wireless LAN may exist using a different IEEE protocol,         802.11b, 802.11g or possibly 802.11n. The defining         characteristics of LANs, in contrast to WANs (wide area         networks), include their higher data transfer rates, smaller         geographic range, and lack of a need for leased         telecommunication lines. Current Ethernet or other IEEE 802.3         LAN technologies operate at speeds up to 10 Gbit/s.     -   For the purposes of the present disclosure, the term “low         powered wireless network” refers to an ultra-low powered         wireless network between sensor nodes and a centralized device.         The ultra-low power is needed by devices that need to operate         for extended periods of time from small batteries energy         scavenging technology. Examples of low powered wireless networks         are ANT, ANT+, Bluetooth Low Energy (BLE), ZigBee and WiFi.     -   For the purposes of the present disclosure, the term “ZigBee”         refers to a specification for a suite of high level         communication protocols used to create personal area networks         built from small, low-power digital radios. ZigBee is based on         an IEEE 802 standard. Though low-powered, ZigBee devices often         transmit data over longer distances by passing data through         intermediate devices to reach more distant ones, creating a mesh         network; i.e., a network with no centralized control or         high-power transmitter/receiver able to reach all of the         networked devices. The decentralized nature of such wireless         ad-hoc networks makes them suitable for applications where a         central node can't be relied upon. ZigBee may be used in         applications that require a low data rate, long battery life,         and secure networking. ZigBee has a defined rate of 250 Kbit/s,         best suited for periodic or intermittent data or a single signal         transmission from a sensor or input device. The technology         defined by the ZigBee specification is intended to be simpler         and less expensive than other WPANs, such as Bluetooth® or         Wi-Fi. Zigbee networks are secured by 128 bit encryption keys.     -   Suitable wireless pairing protocols between the PAP device and         remote activity tracker or other sleep detection device are         disclosed in US patent publication 2014/0281547, entitled         Wireless Pairing of Personal Health Device with a Computing         Device, the disclosure of which is hereby incorporated by         reference in its entirety herein.     -   Since different currently available activity trackers may         utilize different protocols (e.g., some may utilize Bluetooth,         others may utilize ANT or ANT+), the communication module 250         carried by the PAP device of the present invention is preferably         but not necessarily able to pair utilizing any of a variety of         protocols so that it can universally obtain sleep onset data         from whatever device the user may choose to utilize. Thus, the         communication module may be provided with a capability to         communicate utilizing at least two and preferably but not         necessarily at least three or four or more different protocols.         It can be programmed to detect the appropriate protocol from a         sleep detector in range and select that protocol automatically         for a given activity tracker or other source device.         Alternatively, a user may be provided with a choice from an         array of different communication modules from which they can         select the module capable of communication with their sleep         onset detector. The selected module can then be plugged into a         transceiver docking port on the CPAP device followed by pairing         as is understood in the art. The CPAP device may thus be         provided with a port for removably receiving the selected         communication module.     -   The accessory devices that the present system communicates with         can be various items that have the ability to sense sleep onset         and or sleep stage. Exemplary accessory devices can sense sleep         state in a variety of ways: movement, breath rate, blood         pressure, heart rate, eye motion, temperature, sound, brain         activity, physiological activity such as kidney function, GI         function, hormone production and delivery. Such accessory         devices may comprise a Fit Bit or other accessory device that         already has sleep sensing capabilities, and may communicate, for         instance wirelessly, with the blower box and tell it whether the         person is asleep or awake, so that the blower box can respond by         turning on or off based on the sleep state that is reported to         it.     -   From observing changes in behavior and responsiveness,         scientists have noted the following characteristics that         accompany and in many ways define sleep: sleep is a period of         reduced activity; sleep is associated with a typical posture,         such as lying down with eyes closed in humans; sleep results in         a decreased responsiveness to external stimuli; sleep is a state         that is relatively easy to reverse (this distinguishes sleep         from other states of reduced consciousness, such as hibernation         and coma).     -   From observations of behavioral changes that accompany sleep and         simultaneous physiological changes, scientists now define sleep         in humans based on brain wave activity patterns and other         physiological changes as described below.

Many physiological variables are controlled during wakefulness at levels that are optimal for the body's functioning. A person's temperature, blood pressure, and levels of oxygen, carbon dioxide, and glucose in the blood remain quite constant during wakefulness. During sleep, however, physiological demands are reduced and temperature and blood pressure drop. In general, many physiological functions such as brain wave activity, breathing, and heart rate are quite variable when a person is awake or during REM sleep, but are extremely regular when a person is in non-REM sleep.

-   -   For centuries, physicians believed that sleep was a period of         brain inactivity, yet research over the last 60 years has shown         us that the brain remains active during sleep. There is a         progressive decrease in the activation or “firing” rate of most         neurons throughout the brain as sleep progresses from         wakefulness to non-REM sleep. Also, the patterns of neuron         firing change from a seemingly random and variable activity         pattern during wakefulness, to a much more coordinated and         synchronous pattern during non-REM sleep.     -   During REM sleep (the stage of sleep most associated with         dreaming) there is an increase in the firing rate of most         neurons throughout the brain, as compared to non-REM sleep. In         fact, the brain in REM sleep can even be more active than when         awake. Patterns of brain activity during REM sleep are more         random and variable, similar to during wakefulness. This pattern         of brain activity during REM sleep probably underlies the         intense dreaming that occurs during this state.     -   Through a process known as thermoregulation, the temperature of         our body is controlled by mechanisms such as shivering,         sweating, and changing blood flow to the skin, so that body         temperature fluctuates minimally around a set level during         wakefulness. Just before a person falls asleep, their body         begins to lose some heat to the environment, which some         researchers believe actually helps to induce sleep. During         sleep, the body's central set temperature is reduced by 1 to         2° F. As a result, people use less energy maintaining their body         temperature. It has been hypothesized that one of the primary         functions of sleep is to conserve energy in this way.     -   Body temperature is still maintained, although at a slightly         reduced level during non-REM sleep, but during REM sleep body         temperature falls to its lowest point. Sleeping under a blanket         during the usual 10-to 30-minute periods of REM sleep ensures         that people do not lose too much heat to the environment during         this potentially dangerous time without thermoregulation.     -   Breathing patterns also change during sleep. When a person is         awake, breathing is usually quite irregular, since it is         affected by speech, emotions, exercise, posture, and other         factors. As a person progresses from wakefulness through the         stages of non-REM sleep, their breathing rate slightly decreases         and becomes very regular. During REM sleep, the pattern becomes         much more variable again, with an overall increase in breathing         rate.     -   One of the possible functions of sleep is to give the heart a         chance to rest from the constant demands of waking life. As         compared to wakefulness, during non-REM sleep there is an         overall reduction in heart rate and blood pressure. During REM         sleep, however, there is a more pronounced variation in         cardiovascular activity, with overall increases in blood         pressure, heart rate, and blood flow.     -   For the most part, many physiological activities are reduced         during sleep. For example, kidney function slows and the         production of urine is decreased. However, some physiological         processes may be maintained or even increased during sleep. For         example, one of the greatest changes induced by sleep is an         increase in the release of growth hormone. Certain physiological         activities associated with digestion, cell repair, and growth         are often greatest during sleep, suggesting that cell repair and         growth may be an important function of sleep.     -   One of the most notable but least understood characteristics of         sleep is dreaming, during which a person's thoughts may follow         bizarre and seemingly illogical sequences, sometimes random and         sometimes related to experiences gathered during wakefulness.         Visually intense dreaming occurs primarily during REM sleep.         However, not all dreams occur during REM sleep. For example,         night terrors actually occur during non-REM sleep.     -   Varying explanations for dreaming, as well as the meanings of         dreams, have been offered by philosophers and psychologists         throughout history. Even with recent scientific investigations         of dreaming, dreams still remain something of a mystery. Some         experts suggest that dreams represent the replay of the day's         events as a critical mechanism in the formation of memories,         while others claim that the content of dreams is simply the         result of random activity in the brain.     -   Any of the suitable technologies and materials set forth and         incorporated herein may be used to implement various example         aspects of the invention as would be apparent to one of skill in         the art.     -   While CPAP is used throughout this disclosure, it would be         apparent to those of skill in the art that the devices, methods         and structures disclosed in this application may be used in         systems that do not require or use constant positive airway         pressure. Indeed as shown in FIG. 11 herein and the related         discussion, the pressure need not be constant. Thus, the         teachings herein are not limited to CPAP but apply equally to         PAP (Positive Airway Pressure) systems and treatments for sleep         apnea.     -   Although exemplary embodiments and applications of the invention         have been described herein including as described above and         shown in the included example Figures, there is no intention         that the invention be limited to these exemplary embodiments and         applications or to the manner in which the exemplary embodiments         and applications operate or are described herein. Indeed, many         variations and modifications to the exemplary embodiments are         possible as would be apparent to a person of ordinary skill in         the art. The invention may include any device, structure,         method, or functionality, as long as the resulting device,         system or method falls within the scope of one of the claims         that are allowed by the patent office based on this or any         related patent application. 

1. A valve structure for treating a patient suffering from obstructive sleep apnea, the valve structure adapted to be connected to an air flow generator and connected to a mask that covers at least the nostrils of a patient, the valve structure comprising: an inlet pressure port constructed to be attached to the air flow generator; an expiration valve comprising an expiratory membrane and a primary seat and a secondary seat, wherein during inspiration by the patient the expiratory membrane forms a seal with the primary seat, and wherein during expiration by the patient the expiratory membrane forms a seal with the secondary seat.
 2. The valve structure of claim 1, the expiration valve further comprises an opening pressure, and the opening pressure is variable and dependent on the pressure of air in the inlet pressure port as follows: (1) the opening pressure of the expiration valve increases when the pressure of air in the inlet pressure port increases; and/or (2) the opening pressure of the expiration valve decreases when the pressure of air in the inlet pressure port decreases.
 3. The valve structure of claim 1, further comprising: an inspiration valve constructed to allow air flow from the outside of the mask into the mask with little resistance and block air flow from within the mask to the outside of the mask.
 4. The valve structure of claim 3, wherein the inspiration valve comprises two valves.
 5. The valve structure of claim 3, further comprises an ambient pressure port, wherein the inspiration valve and the expiration valve are fluidly connected to the ambient port.
 6. The valve structure of claim 1, further comprising an inlet pressure valve that is constructed to allow air flow from the air flow generator into the mask with little resistance and block air flow from within the mask to the air flow generator.
 7. The valve structure of claim 1, wherein the valve structure is a cartridge.
 8. The valve structure of claim 1, wherein the valve structure is removable from the mask.
 9. A valve structure for treating a patient suffering from obstructive sleep apnea, the valve structure adapted to be connected to an air flow generator and connected to a mask that covers at least the nostrils of a patient, the valve structure comprising: an inlet pressure port constructed to be attached to the air flow generator; an inlet pressure valve connected to the inside of the mask and to the inlet pressure port; an expiration valve connected to the pressure port comprising an expiratory membrane and a primary seat and a secondary seat; an inspiration valve fluidly connected to the inside of the mask and to the outside of the mask; the valve structure having at least an inspiration mode, a rest/apnea mode and an expiration mode; the inspiration mode occurs when the patient inspires air, during which the inspiration valve and the inlet pressure valve are open, and the expiratory membrane forms a seal with the primary seat; the rest/apnea mode occurs when the patient is neither inspiring air nor expiring air, during which the inlet pressure one-way-valve is open, the expiratory membrane forms a seal with the primary seat, and inspiration valve are closed; and the expiration mode occurs when the patient expires air, during which the expiratory membrane forms a seal with the secondary seat and the inlet pressure valve and the inspiration valve are closed.
 10. The valve structure of claim 9, wherein the valve structure comprises a disconnected mode when the air flow generator is not providing airflow to the valve structure: during which when a patient inspires the inspiration valve opens and the expiratory membrane forms a seal with the primary seat; and during which when a patient expires the inspiration valve is closed and the expiratory membrane forms a seal with the secondary seat.
 11. The valve structure of claim 9, wherein the valve structure comprises a disconnected mode when the air flow generator is not providing airflow to the valve structure: during which when a patient inspires the inspiration valve is open; and during which when a patient expires the inspiration valve is closed.
 12. A system for treating a patient suffering from obstructive sleep apnea, system comprising: an air flow generator; a tube connected to the air flow generator; a mask constructed to cover at least the nostrils of the patient, the mask comprising: an inlet pressure port constructed to be attached to the air flow generator; an expiration valve comprising an expiratory membrane and a primary seat and a secondary seat, wherein during inspiration by the patient the expiratory membrane forms a seal with the primary seat, and wherein during expiration by the patient the expiratory membrane forms a seal with the secondary seat.
 13. The system of claim 12, wherein the expiratory valve further comprises an opening pressure, and the opening pressure is variable and dependent on the pressure of air in the inlet pressure port as follows: (1) the opening pressure of the expiration valve increases when the pressure of air in the inlet pressure port increases; and/or (2) the opening pressure of the expiration valve decreases when the pressure of air in the inlet pressure port decreases.
 14. The system of claim 12, wherein the mask further comprises: an inspiration valve constructed to allow air flow from the outside of the mask into the mask with little resistance and block air flow from within the mask to the outside of the mask.
 15. The system of claim 14, wherein the inspiration valve comprises two valves.
 16. The system of claim 14, wherein the mask further comprises an ambient pressure port, wherein the inspiration valve and the expiration valve are fluidly connected to the ambient port.
 17. The system of claim 14, wherein the mask further comprises an inlet pressure valve that is constructed to allow air flow from the air flow generator into the mask with little resistance and block air flow from within the mask to the air flow generator.
 18. The system of claim 12, wherein the expiration valve is part of a cartridge that is removable from the mask.
 19. The system of claim 14, wherein the expiration valve and inspiration valve are part of a cartridge that is removable from the mask.
 20. The system of claim 17, wherein the expiration valve, inspiration valve, and the inlet pressure valve are part of a cartridge that is removable from the mask.
 21. The system of claim 13, wherein the air flow generator further comprises a controller that adjusts an air flow pressure and volume to be generated.
 22. The system of claim 21, wherein the controller comprises a delay circuit that delays the generation of air flow from the air flow generator for a predetermined amount of time.
 23. The system of claim 22, wherein a predetermined maximum pressure is set and the air flow generator gradually increases the pressure of air generated until the maximum pressure is reached.
 24. The system of claim 22, further comprising a sleep detector that signals the controller that the patient is asleep, thus activating the generation of air flow from the air flow generator.
 25. The system of claim 24, wherein a predetermined maximum pressure is set and the air flow generator gradually increases the pressure of air generated until the maximum pressure is reached.
 26. The system of claim 24, wherein the sleep detector is worn by the patient and is adapted to take biometric readings of the patient.
 27. The system of claim 24, wherein the sleep detector is wirelessly connected to the controller. 